Luminex Molecular Diagnostics, Inc. · Class II · Cleared Aug 26, 2010
| K-number | K093420 |
| Device name | XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254) |
| Applicant | Luminex Molecular Diagnostics, Inc. |
| Product code | NTI |
| Device class | Class II |
| Decision date | Aug 26, 2010 |
| Decision | Substantially Equivalent |
| Regulation | 862.3360 |
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